The effect of discontinuation of angiotensin-II receptor blocker on therapeutic effect of synthetic erythropoietin on anemia modification in hemodialysis patients
evaluate the effect of discontinuation of losartan in response to synthetic erythropoietin therapy on hemoglobin level in hemodialysis patients
Design
Clinical trial; pre- and post-treatment
Settings and conduct
The population of this study is hemodialysis patients with ٍend stage renal disease who referred to Mashhad academic hospitals in 1397. After observing the inclusion/exclusion criteria, the level of hemoglobin changes in patients before and three months after removal of losartan drug will compared.
Participants/Inclusion and exclusion criteria
All hemodialysis hypertensive patients who were treated with losartan for at least three months were included. In all patients, no changes in the dose of erythropoietin and iron as well as carnitine supplements will given from three months before and during the three-month intervention period. In addition, any serious infection (leading to hospitalization), obvious bleeding, or history of blood and its products transfusion, as well as any type of surgery, exclud from the study. ferritine level less than 100 ng/ml or CRP more than 10 mg/L will also exluded from the study. Dialysis session duration and frequencies will remined constant, otherwise will excluded.
Intervention groups
Control group: Patients who have received losartan for at least three months
case group: The same patients in the control group who stopped taking losartan for 3 months
Main outcome variables
hemoglobin modification
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190127042516N1
Registration date:2019-02-13, 1397/11/24
Registration timing:registered_while_recruiting
Last update:2019-02-13, 1397/11/24
Update count:0
Registration date
2019-02-13, 1397/11/24
Registrant information
Name
Mahmood Reza Khazaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 1279
Email address
khazaeem@mshdiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-09, 1397/11/20
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of discontinuation of angiotensin-II receptor blocker on therapeutic effect of synthetic erythropoietin on anemia modification in hemodialysis patients
Public title
Effect of Losartan discontinuation on treatment of anemia in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All hypertensive patients with ESRD on regular hemodialysis consist of 3 4-hours session per week.
Use of Losartan at least the last three months
Exclusion criteria:
Dosage alteration for rHuEPO, ferrous sulfate and Carnitine supplementation.
Serious infection leading hospitalization
Obvious bleeding
Transfusion
Surgery
CRP>10 mg/L
Serum Ferritin <100 ng/ml
Any alteration in hemodialysis dosage/time
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
More than 1 sample in each individual
Number of samples in each individual:
2
Two samples are taken from each person. The first stage was immediately before the discontinuation of the drug (as the control group) and the second one, 3 months after the discontinuation (as the case group)
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This research is a clinical trial and pre- and post-intervention method. The duration of the intervention is three months. The values of the relevant variable (hemoglobin level) before the treatment intervention (control group) will compared with the values after the discontinuation of the drug (test group). Immediately prior to discontinuing and replacing losartan, the venous blood sample is taken as a control group for testing.The losartan will discontinued and the blood pressure will controlled with the oral antihypertensive medication other than ACE-I or ARB categories. After three months of treatment intervention, blood samples are taken again as the test group. Blood samples of 5cc from the intravenous line of vascular access are obtained immediately before hemodialysis. Blood hemoglobin level (gr / dl) is measured with Cell Counter Mindry BC 3000Plus machine.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee in bio-medicine research - Mashhad branch
Street address
Sarab Ave., Azadi st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185666773
Approval date
2018-09-05, 1397/06/14
Ethics committee reference number
IR.IAU.MSHD.REC.1397.028
Health conditions studied
1
Description of health condition studied
Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease
ICD-10 code
I13.11
ICD-10 code description
Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease
Primary outcomes
1
Description
Hemoglobin increment
Timepoint
Before intervention and 3 months after discontinuation of Losartan
Method of measurement
Cell Counter Mindry BC 3000Plus machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Discontinuation of Losartan
Category
Treatment - Drugs
2
Description
Control group: Hemodialysis patients on Losartan for at least 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman hospital
Full name of responsible person
Mahmood Reza Khazaei
Street address
Telgerd, Golshahr
City
Mashhad
Province
Razavi Khorasan
Postal code
91577 94985
Email
khazaeem@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
َAbtahi Saeed
Street address
Sarab Ave., Azadi St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91577 94985
Phone
+98 51 3225 0049
Fax
+98 51 3225 0048
Email
sabtahimd@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?